In talking with experts and reviewing the drugs that have been approved over the past couple of years, we believe it is our right to ask Congress to hold a hearing to review the denial of Ampligen.  Below is a draft letter along with the email addresses where the letter should be sent.  It is clear the drug provides benefits and we know that once a drug would be approved other treatments would soon follow.

capitol building - hearing - chronic fatigue syndrome

A Congressional Hearing – to review what can be done to get Ampligen out to the ME/CFS Community

We will be meeting with Congressional leaders on the hill on this request.  Please, join us in this campaign.

Robert Miller, Lori Chapo Kroger, Billie Moore, Pat LaRosa, Cort Johnson, Anita Patton

The FDA has found creative ways to get other drugs out to other “medically underserved” patient groups, yet it has chosen not to do so with Ampligen.

Even after the FDA agreed that safety – the key concern at the FDA hearing – is no longer an issue, no movement has been made in making this drug available.

Advocates recently played a key role in having the FDA reverse a similar decision on a multiple sclerosis drug. Please use the letter below to help us call for a Congressional hearing to illuminate how the needs of the ME/CFS community are not being met.

Cort Johnson

The Letter

Please note that the email address belong to congressional staff members (Monica Volante – Rep Pitts, Sarah Curtis – Rep Kennedy, Mark Ratner – Rep. Upton, etc.)

Email to: Monica.volante@mail.house.gov; sarah.curtis@mail.house.gov; Elizabeth.brown@mail.house.gov; dennis.sills@mail.house.gov; mark.ratner@mail.house.gov; james.pauskiewicz@mail.house.gov; brad.grantz@mail.house.gov; thomas.power@mail.house.gov; janet.woodcock@fda.hhs.gov; Margaret.hamburg@fda.hhs.gov; HearUsMECFS@yahoo.com

The Body of the Letter

  • To: The Honorable Congressman Joseph Pitts.  Chairman, Energy and Commerce, Subcommittee on Health
  • To:  Representatives Kennedy, Castor, Butterfield, Upton, Burgess, Murphy, Bilirakis
  • Cc:  Janet.Woodcock, Director, Center for Drug Evaluation and Research

From:  _________________________________

Subject:  Request for Hearing on ME/CFS treatment denial

I am writing to you on behalf of one million patients in the US and 17 million more worldwide that are disabled and suffering from Myalgic Encephalomeylitis, (poorly identified as Chronic Fatigue Syndrome), ME/CFS. We are writing to request that you conduct a hearing to examine the denial of access to treatment for this disease by the FDA.   One drug over the course of 20 + years has demonstrated that it can improve the lives of a significant proportion of the patients suffering from this life-robbing illness, and yet we are still denied access to the drug.

We believe that a hearing and or independent adjudication is the only path to justice.  Below are a few of the critical issues that must be addressed:

1)  The experts in the field and the FDA advisory panel say it is safe for approval. Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research and members of the current Rheumatology Division agreed at a meeting with experts, patients and the drug company that safety was not the issue;  but are simply unclear on efficacy.

2) The FDA has stated that this is a serious, life-threatening and complex illness.  The FDA has the regulatory authority to provide expanded access via approval with conditions.  Experts with decades of experience with the disease and the drug are willing work with the FDA to design the conditional studies. The drug manufacturer has offered to implement an extensive REMS (Risk Evaluation and Mitigation Strategy) program that would educate physicians, patients, and pharmacists on the diagnosing and treating ME/CFS and the safe and appropriate use of the drug.

3)  The drug has been used in patients for more than 20 years and over 100,000 doses.  Experts agree that they have seen improvement in approximately 40% of the patients using the drug.

4)  Seven hundred patients provided testimony at the FDA advisory meeting for this drug’s approval.  Four thousand signed a petition requesting the drug be approved.  That was in 2012.  Patients have been suffering for decades at a cost of $22 billion a year.

5) The small bio-tech company is the only company that recognized the severe nature of this disease has been shuffled through five FDA divisions, with each division applying new and different standards and requirements for approval.  After the denial, the FDA lead reviewer admitted at a public meeting she did not understand the disease.

6)  FDA’s appeals process is highly flawed.  A top regulatory law firm, Hyman Phelps, stated in presentation that any company utilizing this path would require deep pockets and years without necessarily any hope of approval.

7)  Currently there are no approved treatments, and it will be years if not decades before any other treatment may be approved.  AZT was far from perfect, yet once approved it opened the gate for other drugs for HIV/AIDS; within 9 years 13 drugs were approved. Today AIDS patients live long and fruitful lives.  ME/CFS patients cling to a tiny bit of hope.

As a patient that has endured this disease for ___ years, I am willing to take the risks and want the right to choose, with the help of my physician, to use Ampligen.  Why are only those who can afford allowed access to it through trial programs?  The obesity drugs were approved with conditions, a recently approved Multiple Sclerosis drug has severe sometimes fatal side effects, and a Leukemia drug was just approved with only a Phase II study.  Why is my life worth less than those patients’ lives?!

You are our only recourse.  The FDA has swept us into a dark closet.  We believe the FDA must be brought to the table, and a HEARING would allow for the experts to be heard by a fair and impartial group.  We also believe this process will shed light on many other drugs and diseases where FDA is failing to provide public health.

This is America, but not an America we can participate in because of ME/CFS.  Please call a hearing and listen to the experts.  Give us the chance at the health care we deserve.



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